The Occupational Safety and Health Administration (OSHA) has determined that soft tissue injuries are a leading cause of lost work, time and productivity. Soft tissue injuries cost over $200 billion annually in lost man-hours and medical costs. In fact, soft tissue injuries are responsible for 80 percent of all Workers Compensation claims. Soft tissue injuries are often non-specific, difficult to diagnose and treat, and current subjective diagnostics can be a “process of elimination”. In addition, it is often difficult to determine when a soft tissue injury has occurred.
In the medical community, it is well known that muscle compensation patterns can be used to differentiate chronic versus acute injuries. Acute injuries are typically exemplified by muscle spasm and hyperactivity. Chronic injuries are typically associated with compensation, bilateral changes, and absence of a reflection relaxation response. It is also a fact that many physicians deal with complaints and injuries that involve soft tissue injury, particularly cervical, thoracic, lumbosacral and extremities. All muscle groups of the body, from the cervical including the mid, thoracic, lumbosacral and upper and lower extremities, can be monitored using the EFA-3 for both humans and animals. This is extremely beneficial because a typical soft tissue injury may be chronic or acute, with no physical indicators. Direct palpitation of a soft tissue injury can, in some cases, reveal the nature or type of injury, but this manner of diagnosis relies on static testing and on individual tests that are performed separately, which are less reliable than combining and integrating the evaluations of Electromyography (EMG), range of motion (ROM) and functional assessment. To enhance and correlate the above tests, physiological parameters, cardiac response, temperature, nerve testing, brain wave activity and blood flow can also be monitored.
The combination of these tests, unlike any other test, does not rely on the coefficients of variance but measures muscle activity while simultaneously monitoring range of motion, functional assessment, grip strength, pinch strength, cardiac response, temperature and nerve and brain wave activity either alone or in combination. This dynamic integration provides an analysis of Type I versus Type II motor units, which coordinate with an effort produced by the individual who is being tested. Furthermore, when disc pathology is present there is a chemical released in the individual's blood supply, which causes ischemic changes in the surrounding musculature. The benefit of quantifying these conditions in a non-invasive and portable manner is that the amount of ischemia/vasoconstriction in the surrounding blood tissue correlates with the degree of disc pathology, thereby allowing treatment recommendations to be made, i.e. surgery versus physical therapy. The benefit of the EFA-3 is its ability to monitor and site-specifically treat muscles, nerves and other bodily functions.
In the past, various technological tests such as EMG, range of motion, cardiac information or functional assessments were singularly relied upon to determine the cause of muscle activity. However, when the tests are performed alone they are less objective. By integrating all of the functions of the EFA-3 it is possible to acquire a more objective assessment of any specific treatment.
The costs of treating the above-described problems are expected to increase, especially with OSHA considering new ergonomic standards. With the implementation of the American's with Disabilities Act (ADA) workers compensation claims have increased, especially claims of Carpal Tunnel Syndrome (CTS) which are expected to exceed 40 billion dollars per year within the next five years. CTS problems are also often misdiagnosed, for example, referred pain from the scalene muscle can mimic the symptoms of lunar neuropathy, carpal tunnel syndrome or even thoracic outlet syndrome. The misdiagnosed above problems are in reality a muscle problem in the front of the neck.
A recent study demonstrates that 45 percent of individuals who have undergone CTS surgery receive no relief and show no improvement at a two year follow up. The lack of improvement can be attributed to the inability to identify the soft tissue component. Furthermore, 65 percent of individuals who have undergone back surgery resulted in failed back syndrome or have no relief of symptomology. This can also be attributed to an inability to properly diagnose and age a soft tissue injury. In the past, prior art has not been capable of performing a proper diagnosis.
Until the advent of the EFA-3 it was not possible to incorporate all of functions required to perform a comprehensive diagnostic test in a reliable, cost effective and user-friendly manner. The uniqueness of the EFA-3 is the utilization of remote and wireless sensor(s) which provide portability and increased ease of use. The wireless sensor(s) can have a disposable component, and any proprietary sensor(s) that are not disposable have their own battery-recharging unit. This allows for no down-time during monitoring and, since the sensor(s) can be interchangeable, if one sensor(s) is not functioning, a replacement is immediately available. Therefore, an unlimited combination of testing possibilities is available depending on the protocols required. The EFA-3 is operated remotely, by utilizing GiFi, WiFi, ZIGBEE™, BLUETOOTH™, or any other standard or proprietary wireless system.
A search of the prior art did not disclose any patents that read directly on the claims of this instant invention, however the following patents and publications are considered related:
Pat. No.INVENTORISSUE DATE6,678,549Cusimano, et al13 Jan. 20045,513,651Cusimano, et al7 May 19965,462,065Cusimano, et al31 Oct. 19955,042,505Mayer, et al27 Aug. 19914,688,581Moss25 Aug. 19874,667,513Konno26 May 198720060058699Vitiello et al19 Apr. 2005
The U.S. Pat. No. 6,678,549, which is owned by the applicants of the instant application, discloses a system that combines Electromyography (EMG), Range of Motion (ROM), and Nerve Conduction Velocity (NCV). It differs from the instant application in that it is not an integrated unit and is only used to test humans. The system also does not allow for remote monitoring, blood flow monitoring or the use of various Range of Motion (ROM) implements, and uses an interface that does not allow for the rapid exchange of data.
The U.S. Pat. Nos. 5,513,651 and 5,462,065, which are owned by the applicants of the instant application, disclose an integrated movement analyzing system (IMA) that utilizes surface EMG in combination with range of motion and functional capacity testing to monitor muscle groups in the human body. The system consists of an integrated movement analyzer (IMA) that receives inputs from surface EMG electrodes, a range of motion analyzer (ROMA), and a functional capacity sensor(s). When performing upper and lower back testing, the ROMA is connected between the subject's upper back and the lower back by a shoulder harness and a waist belt.
For cervical testing, the ROMA is connected between the subject's head and the upper back by a cervical cap and the shoulder harness. The output of the IMA is provided via an analog to digital converter to a computer. The computer, in combination with a software program, produces an output consisting of comparative analytical data. This data is taken via a parallel port and multiple a/d cards while the subject is not isolated. This system can not be used remotely, has hardwired cables and does not have the capability to monitor physiological properties except for EMG, range of motion, FCE, pinch and grip.
The U.S. Pat. No. 5,042,505 discloses an electronic device for measuring relative angular positional displacement and angular range of motion for body segments and articulating joints of the human skeleton. The device has a hand-held interface unit, which is placed against the body segment or joint to be tested. Mounted within the housing of the interface unit is a shaft with a pendulum at one end and an optical encoder at the other. As the body segment rotates or the joint articulates, the pendulum swings in the direction of gravity, causing the shaft to rotate. The optical encoder generates an electrical signal representative of the amount of rotation of the shaft. The generated signal is fed to a microscope which processes the signal and produces on a display the change in angular position relative to the initial angular position or the angular range of motion of the body segment or articulating joint.
The U.S. Pat. No. 4,688,581 discloses an apparatus and a method for non-invasive in-vivo determination of muscle fiber composition. The method includes the steps of electrically stimulating a chosen muscle, determining the stimulation current, measuring the electrical stimulating a chosen muscle, determining the stimulation current, measuring the electrical potential of the muscle, the contraction time and the force produced by the contraction. By intercorrelating the data by multiple regression, the type, percentage and size of the muscle fibers within the muscle stimulated can be determined. The apparatus determines muscle composition and includes a muscle stimulator of controlled voltage, electromygram equipment and a force transducer, that in combination provide a tension curve as well as force measurements.
The U.S. Pat. No. 4,667,513 discloses an apparatus and a method for estimating the degree of the fatigue and pain of muscles. The apparatus tests subjects of different weights on the same basis by deriving the variation in the muscular strength such as dorsal muscular strength, shoulder muscular strength, grasping strength and the like. An analogous electric signal integrates the muscular output and provides an integrated value of the electromyogrammatic amplitude by processing the voltage induced from the muscle to be tested through an electromygram amplitude and waveform processor. The ratio between these integrated values after correlating the ratio with the weight/muscular strength coefficient is digitally displayed.
The 20060058699 publication discloses a non-integrated system that is used to test humans by combining EMG and ROM. The system does not allow remote monitoring, blood flow monitoring or different ROM, utilizes an interface that does not allow for the rapid exchange of data and uses multiple data acquisition cards. The system also uses an electromagnetic field for range of motion that can be ineffective and even harmful to individuals who have post surgical hardware or pacemakers.
For background purposes and as indicative of the art to which the invention relates, reference may be made to the following remaining patents and publications found in the search:
Pat. No.INVENTORISSUE DATE5,056,530Butler, et al15 Oct. 19915,050,618Larsen24 Sep. 19915,042,505Meyer, et al27 Aug. 19915,038,795Roush, et al13 Aug. 19915,012,820Meyer7 May 19914,938,476Bryunnell, et al3 Jul. 19904,928,709Allison, et al29 May 19904,886,073Dillion, et al12 Dec. 19894,845,987Kenneth11 Jul. 19894,834,057McLeod, Jr30 May 19894,805,636Barry, et al21 Feb. 19894,800,897Nilsson31 Jan. 19894,742,832Kauffmann, et al10 May 19884,667,513Konno26 May 19874,586,515Berger6 May 198620070230270Calhoun; Robert B.4 Oct. 2007